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NCT00546858 Clinical Trial

Relationship of Interstitial Cystitis to Vulvodynia

Interstitial Cystitis Clinical Trial

Official title:
Part A: STUDY OF THE RELATIONSHIP OF INTERSTITIAL CYSTITIS TO VULVODYNIA

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00546858
Other study ID # 2007-183
Secondary ID
Status Completed
Phase N/A
First received October 18, 2007
Last updated May 4, 2009
Start date October 2007
Est. completion date May 2009

Study information
Verified date May 2009
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is important in urologic nursing since many patients have interstitial cystitis (IC), a condition of frequency, urgency and pain affecting more than 1 million women in the United States. The vulva may actually be the site of some of the reported pain in women with IC, not the urethra or bladder. IC and vulvodynia can impact one's sexual functioning and diminish one's quality of life.

The purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC).

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Females who are 18 years of age and older.

- Diagnosis of interstitial cystitis

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Physical Examination
Patients will be invited to be evaluated in the Urology Research office at a future date.

Locations
Country Name City State
United States William Beaumont Hospital Royal Oak Michigan

Sponsors (1)
Lead Sponsor Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC). Prospective
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